ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma
Circulating Tumor DNA-based Minimal Residual Disease (MRD) Assessment in Local Advanced Esophageal Squamous Cell Carcinoma Treated by Definitive Concurrent Chemoradiotherapy
1 other identifier
observational
100
1 country
1
Brief Summary
To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJune 22, 2022
June 1, 2022
1.6 years
May 24, 2022
June 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Relationship between ctDNA status after chemoradiotherapy and relapse.
To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.
ctDNA will be tested within 1 year after chemoradiotherapy
Secondary Outcomes (4)
Changes of ctDNA status.
before and at the end of radiotherapy (+1 week); at the end of consolidation chemotherapy (+1 week); at 2 weeks, 1 month, 3 months, 6 months, 9 months, 1 year after dCCRT.
Overall survival (OS).
through study completion, an average of 2 years.
Relapse-free survival (RFS) and progression-free survival (PFS).
through study completion, an average of 2 years.
Relationships between radiomics features, ctDNA status and relapse.
through study completion, an average of 2 years.
Study Arms (2)
ctDNA(+) Cohort
ctDNA(+) Cohort in pretreatment and posttreatment plasma samples was defined by accessing the presence of one or more mutations identified in match tumor samples.
ctDNA(-) Cohort
ctDNA(-) Cohort in pretreatment and posttreatment plasma samples was defined by the absence of one or more mutations identified in match tumor samples.
Eligibility Criteria
Local advanced esophageal squamous cell carcinoma treated by definitive concurrent chemoradiotherapy
You may qualify if:
- years old.
- ECOG 0-1.
- Esophageal squamous cell carcinoma confirmed by pathology.
- No radiotherapy, chemotherapy, or other treatments prior to enrollment.
- Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).
- No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency.
- Informed consent signed.
You may not qualify if:
- Less than 50.4Gy/28fx of radiotherapy dose.
- Without Concurrent chemotherapy.
- Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 22, 2022
Study Start
June 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 1, 2024
Last Updated
June 22, 2022
Record last verified: 2022-06